Recall Z-0542-2014— CooperVision Inc.
Class II · Terminated
Class II FDA medical device recall by CooperVision Inc., initiated 2013-11-20, terminated 2015-07-22. It names one FDA 510(k) clearance: K061948. Product: Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses. Reason: Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date..
- Recalling firm
- CooperVision Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-20
- Terminated
- 2015-07-22
- Firm location
- W Henrietta, NY, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Pro clear(R) 1 day Sphere (o mafilcon A), 90 daily disposable contact lenses, STERILE, Rx ONLY --- Coopervision Shamble, SO 31 4 RF, UK - Scottsville, NY 14546 USA - Juana Diaz, PR 00795 USA daily use disposable contact lenses
Reason for recall
Lots were labeled with incorrect expiration dates on secondary package (carton). The primary package (blister) is marked with the correct expiration date.
Data sourced from openFDA. This site is unofficial and independent of the FDA.